NCT01979341

Brief Summary

The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole use results in reduced embryo implantation due to luteal phase insufficiency. The combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to overcome the luteal phase insufficiency effecting endometrial receptivity. In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in normoresponders will increase oocyte maturity, embryo quality and embryo implantation and reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose) alone trigger.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

2.7 years

First QC Date

November 1, 2013

Last Update Submit

May 25, 2016

Conditions

PregnancyOvarian Hyperstimulation Syndrome

Keywords

dual triggerhCGGnRH agonistICSIpregnancyOHSS

Outcome Measures

Primary Outcomes (1)

  • embryo implantation rate

    the number of fetal sacs per embryo transferred to a patient's uterus

    12 months

Secondary Outcomes (2)

  • oocyte maturation

    12 months

  • Ovarian hyperstimulation syndrome

    12 months

Other Outcomes (1)

  • clinical pregnancy

    12 months

Study Arms (3)

Dual trigger

ACTIVE COMPARATOR

final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)

Procedure: final oocyte maturation trigger

hCG trigger

ACTIVE COMPARATOR

final oocyte maturation trigger using 6500 IU Ovitrelle (hCG)

Procedure: final oocyte maturation trigger

agonist trigger

ACTIVE COMPARATOR

final oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist)

Procedure: final oocyte maturation trigger

Interventions

final oocyte maturation triggerPROCEDURE

when ≥3 follicles reach 17mm patients will be randomized to receive one of two types of trigger for final oocyte maturation; dual trigger: GnRH agonist plus hCG (both full doses) hCG only: full dose of hCG only

Also known as: dual trigger: 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist), hCG trigger: 6500 IU Ovitrelle (hCG), agonist trigger: 0.2mg triptorelin acetate (GnRH agonist)
Dual triggeragonist triggerhCG trigger

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age; \< 40 years
  • Cycle number; cycles 1 or 2
  • Antral follicle count; \>10 and \<25
  • BMI; \>18 and \<30
  • Normogonadotrophic cycle length; 24 to 25 days
  • Male; ejaculated semen only

You may not qualify if:

  • Presence of endocrine disorders; (diabetes mellitus, hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome)
  • Previous major uterine surgery (that would affect endometrial receptivity)
  • \<5 follicles at the time of trigger
  • \<2 full formed blastocyst on day 5 of embryo culture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya IVF

Antalya, Antalya, 07080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Chorionic GonadotropinTriptorelin PamoateGonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsPituitary Hormone-Releasing HormonesHypothalamic HormonesNeuropeptidesOligopeptidesNerve Tissue Proteins

Study Officials

  • Hasan Bulut, MD

    Antalya IVF

    PRINCIPAL INVESTIGATOR

  • Kemal Ozgur, MD

    Antalya IVF

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Advisor

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 8, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

TU(1)